Buy Rating Reaffirmed on Aquestive Therapeutics as Operational FDA Setbacks De-Risk Anaphylm’s Path to Approval

Francois Brisebois, an analyst from LifeSci Capital, reiterated the Buy rating on Aquestive Therapeutics. The associated price target was raised to $9.00.

Francois Brisebois has given his Buy rating due to a combination of factors that, in his view, significantly de-risk Aquestive Therapeutics’ outlook despite the recent regulatory setback. He notes that the FDA’s Complete Response Letter for Anaphylm is confined to human‑factor and packaging issues—such as how easily the pouch is opened, the clarity of film placement instructions, and patient sensations that might cause early removal—without raising any concerns about the product’s pharmacokinetics, safety, efficacy, or CMC package. This lack of clinical or manufacturing deficiencies is interpreted as validation of the underlying data and a strong signal that Anaphylm’s therapeutic profile remains intact. Management’s plan to redesign packaging and instructions, run a new human‑factors validation alongside a relatively simple PK study, and pursue NDA resubmission as early as the third quarter of 2026 supports his view that the issues are fixable and primarily operational rather than scientific in nature.

Brisebois also emphasizes that the requested labeling changes appear straightforward and that the company intends to seek an expedited review once the NDA is resubmitted, implying a potential approval and commercial launch timeline around 2027. He highlights that real‑world human‑factor data, including only a single reported instance of a child being unable to open the child-resistant pouch among a substantial number of participants and doses, suggests current usability problems are limited and manageable. The increased clarity on the regulatory path, combined with preserved clinical value and a feasible remediation strategy, leads him to view the stock’s risk‑reward profile as more favorable after the CRL. As a result, he reiterates a positive (Outperform/Buy) stance on AQST and supports a higher price target, reflecting his confidence in eventual approval and commercialization of Anaphylm.